Agency Information Collection Activities; Proposed Collection; Public Comment Request, 41507-41508 [2015-17348]
Download as PDF
<![CDATA[
41507
Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices
ICCR is a voluntary international
group of cosmetics regulatory
authorities from the United States,
Japan, the European Union, Canada, and
Brazil. These regulatory authority
members will enter into constructive
dialogue with their relevant cosmetics
industry trade associations and public
advocacy groups. Currently, the ICCR
members are: Health Canada; the
European Commission DirectorateGeneral for Internal Market, Industry,
Entrepreneurship, and Subject Matter
Experts; the Ministry of Health, Labor,
and Welfare of Japan; the Brazilian
Health Surveillance Agency; and FDA.
All decisions made by consensus will be
compatible with the laws, policies,
rules, regulations, and directives of the
respective administrations and
governments. Members will implement
and/or promote actions or documents
within their own jurisdictions and seek
convergence of regulatory policies and
practices. Successful implementation
will need input from stakeholders.
Agenda: We will make the agenda for
the public meeting available on the
Internet at https://www.fda.gov/
Cosmetics/InternationalActivities/ICCR/
default.htm. Depending on the number
of requests for oral presentations, we
intend to have an agenda available by
September 3, 2015. We may use the
information that you provide to us
during the public meeting to help us
prepare for the November 4–6, 2015,
ICCR–9 meeting.
Dated: July 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17248 Filed 7–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: HHS–0990–0279–60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Assistant
Secretary for Health, HHS.
AGENCY:
ACTION:
approve, and have continuing oversight
of research involving human subjects.
The Office for Human Research
Protections (OHRP) and the Food and
Drug Administration (FDA) are
requesting a three-year extension of the
OMB No. 0990–0279, Institutional
Review Board (IRB) Registration Form.
This form was modified in 2009 to be
consistent with IRB registration
requirements, 45 CFR part 46, subpart E
and 21 CFR 56.106 that were adopted in
July 2009 OHRP and FDA, respectively.
Need and Proposed Use of the
Information: The information collected
through the Institutional Review Board
registration collection requirements is
the minimum necessary to satisfy the
registration requirements of Section 491
(a) of the Public Health Service Act, 45
CFR part 46, subpart E and 21 CFR
56.106.
Likely Respondents: Institutions or
organizations operating IRBs that review
human subjects research conducted or
supported by HHS, or, in the case of
FDA’s regulations, IRBs in the United
States that review clinical investigations
regulated by FDA under sections 505(i)
or 520(g) of the Federal Food, Drug and
Cosmetic Act; and, IRBs in the United
States that review clinical investigations
that are intended to support
applications for research or marketing
permits for FDA-regulated products.
Burden Statement: The burden
estimates for the IRB registration form
include those approved by OMB in
March 2015 under Control Number
0990–0263, the Assurance
Identification/IRB Certification/
Declaration of Exemption form (former
Optional Form 310). Those burden
estimates are not included as part of the
burden estimate presented below.
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary, Department of Health and
Human Services (HHS), announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). The ICR is for extending
the use of the approved information
collection assigned OMB control
number 0990–0279, which expires on
August 31, 2015. Prior to submitting
that ICR to OMB, OS seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on the ICR must be
received on or before September 14,
2015.
SUMMARY:
Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier 0990–0279 for
reference.
Information Collection Request Title:
Institutional Review Board Form—OMB
No. 0990–0279, Assistant Secretary for
Health, Office for Human Research
Protections.
Abstract: Section 491(a) of Public Law
99–158 states that the Secretary of HHS
shall by regulation require that each
entity applying for HHS support (e.g., a
grant, contract, or cooperative
agreement) to conduct research
involving human subjects submit to
HHS assurances satisfactory to the
Secretary that it has established an
institutional review board (IRB) to
review the research in order to ensure
protection of the rights and welfare of
the human research subjects. IRBs are
boards, committees, or groups formally
designated by an entity to review,
ADDRESSES:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
IRB Registration 0990–0279 ...........................................................................
5,900
500
2
2
1
1
11,800
1,000
Total ..........................................................................................................
........................
........................
........................
12,800
VerDate Sep<11>2014
18:52 Jul 14, 2015
Jkt 235001
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
E:\FR\FM\15JYN1.SGM
15JYN1
41508
Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices
OS specifically requests comments on
(1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Terry S. Clark,
Asst Information Collection Clearance
Officer.
[FR Doc. 2015–17348 Filed 7–14–15; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Prostate, Lung,
Colorectal and Ovarian Cancer
Screening Trial (PLCO) (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 21, 2015
(80 FR 22211), and allowed 60-days for
public comment. No public comments
SUMMARY:
Proposed Collection: Prostate, Lung,
Colorectal and Ovarian Cancer
Screening Trial (PLCO) 0925–0407,
Revision, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This is a request for a
revision of the Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial
(PLCO). This trial was designed to
determine if cancer screening for
prostate, lung, colorectal, and ovarian
cancer can reduce mortality from these
cancers which caused an estimated
253,320 deaths in the U.S in 2014. The
design is a two-armed randomized trial
of men and women aged 55 to 74 at
entry. OMB first approved this study in
1993 and has approved it every 3 years
since then. Recruitment was completed
in 2001, baseline cancer screening was
completed in 2006, and data collection
continues on the current cohort of
77,281 participants who are actively
being followed. The additional followup will provide data that will clarify
further the long term effects of the
screening on cancer incidence and
mortality for the four targeted cancers.
Further, demographic and risk factor
information may be used to analyze the
differential effectiveness of cancer
screening in high versus low risk
individuals.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
26,320.
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Cancer Institute (NCI), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Kelly Yu, Ph.D., Division of
Cancer Prevention, 9609 Medical Center
Drive, Room 5E230, Rockville, MD
20850 call non-toll-free number 240–
276–7041 or Email your request,
including your address to:
yuke@mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average time
per response
(minutes/
hour)
Annual
burden
hours
Type of respondents
Annual Study Update (ASU) Form ...
ASU Telephone Script ......................
Authorization to Release Medical
Records.
Health Status Questionnaire (Female) (HSQ).
Health Status Questionnaire (Male)
(HSQ).
Medication
Use
Questionnaire
(MUQ).
mstockstill on DSK4VPTVN1PROD with NOTICES
Form name
Participants who complete the ASU
Non Responders to the ASU ...........
Participants who report new cancers
77,281
3,091
2,700
1
1
1
5/60
5/60
3/60
6,440
258
135
Female participants who complete
the HSQ.
Male participants who complete the
HSQ.
Participants who complete the MUQ
960
1
5/60
80
1,040
1
5/60
87
77,281
1
15/60
19,320
Dated: June 23, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–17340 Filed 7–14–15; 8:45 am]
National Cancer Institute; Amended
Notice of Meeting
BILLING CODE 4140–01–P
National Institutes of Health
Notice is hereby given of a change in
the meeting of the National Cancer
VerDate Sep<11>2014
18:52 Jul 14, 2015
Jkt 235001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Institute Special Emphasis Panel, July
22, 2015, 11:00 a.m. to 04:00 p.m.,
National Cancer Institute Shady Grove,
9609 Medical Center Drive, 2W194,
Rockville, MD, 20850 which was
published in the Federal Register on
June 23, 2015, 80 FR 35964.
The meeting notice is amended to
change the date of the meeting from July
E:\FR\FM\15JYN1.SGM
15JYN1
]]>Agencies
[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41507-41508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17348]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: HHS-0990-0279-60D]
Agency Information Collection Activities; Proposed Collection;
Public Comment Request
AGENCY: Office of the Assistant Secretary for Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the Secretary, Department of
Health and Human Services (HHS), announces plans to submit an
Information Collection Request (ICR), described below, to the Office of
Management and Budget (OMB). The ICR is for extending the use of the
approved information collection assigned OMB control number 0990-0279,
which expires on August 31, 2015. Prior to submitting that ICR to OMB,
OS seeks comments from the public regarding the burden estimate, below,
or any other aspect of the ICR.
DATES: Comments on the ICR must be received on or before September 14,
2015.
ADDRESSES: Submit your comments to
Information.CollectionClearance@hhs.gov or by calling (202) 690-6162.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the document identifier 0990-0279 for
reference.
Information Collection Request Title: Institutional Review Board
Form--OMB No. 0990-0279, Assistant Secretary for Health, Office for
Human Research Protections.
Abstract: Section 491(a) of Public Law 99-158 states that the
Secretary of HHS shall by regulation require that each entity applying
for HHS support (e.g., a grant, contract, or cooperative agreement) to
conduct research involving human subjects submit to HHS assurances
satisfactory to the Secretary that it has established an institutional
review board (IRB) to review the research in order to ensure protection
of the rights and welfare of the human research subjects. IRBs are
boards, committees, or groups formally designated by an entity to
review, approve, and have continuing oversight of research involving
human subjects.
The Office for Human Research Protections (OHRP) and the Food and
Drug Administration (FDA) are requesting a three-year extension of the
OMB No. 0990-0279, Institutional Review Board (IRB) Registration Form.
This form was modified in 2009 to be consistent with IRB registration
requirements, 45 CFR part 46, subpart E and 21 CFR 56.106 that were
adopted in July 2009 OHRP and FDA, respectively.
Need and Proposed Use of the Information: The information collected
through the Institutional Review Board registration collection
requirements is the minimum necessary to satisfy the registration
requirements of Section 491 (a) of the Public Health Service Act, 45
CFR part 46, subpart E and 21 CFR 56.106.
Likely Respondents: Institutions or organizations operating IRBs
that review human subjects research conducted or supported by HHS, or,
in the case of FDA's regulations, IRBs in the United States that review
clinical investigations regulated by FDA under sections 505(i) or
520(g) of the Federal Food, Drug and Cosmetic Act; and, IRBs in the
United States that review clinical investigations that are intended to
support applications for research or marketing permits for FDA-
regulated products.
Burden Statement: The burden estimates for the IRB registration
form include those approved by OMB in March 2015 under Control Number
0990-0263, the Assurance Identification/IRB Certification/Declaration
of Exemption form (former Optional Form 310). Those burden estimates
are not included as part of the burden estimate presented below.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
IRB Registration 0990-0279...................... 5,900 2 1 11,800
500 2 1 1,000
---------------------------------------------------------------
Total....................................... .............. .............. .............. 12,800
----------------------------------------------------------------------------------------------------------------
[[Page 41508]]
OS specifically requests comments on (1) the necessity and utility
of the proposed information collection for the proper performance of
the agency's functions, (2) the accuracy of the estimated burden, (3)
ways to enhance the quality, utility, and clarity of the information to
be collected, and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-17348 Filed 7-14-15; 8:45 am]
BILLING CODE 4150-28-P
